Be able to describe the development and key characteristics of clinical practice guidelines
Be able to critically appraise clinical practice guidelines
Be able to describe the challenges of risk communication
Guidelines need to synthesise and interpret evidence to make actionable recommendations
Guidelines need to be critically appraised and implemented with care—it is often useful to know the evidence underlying the recommendations
People are frequently confused by numbers
Use natural frequencies (‘5 out of 100’), provide benefits and harms, and use decision-aids
Developed by an expert panel
Often published by government bodies or professional bodies (e.g. NHMRC, National Asthma Council, Royal Australian College of General Practitioners, etc)
Compile and synthesise available research and clinical experience into actionable recommendations
Typically focus on a particular condition or clinical area (e.g. management of acute coronary syndrome, treatment of osteoarthritis, etc)
Guideline developers will:
Be relevant and useful for decision making
Be transparent in process of development, sources of evidence and funding
Ensure the development group has the right mix of skills and include end-users
Identify and manage conflicts of interest
Be evidence-informed: comprehensive search, explicit criteria for assessing evidence and making recommendations
Make actionable recommendations
Be up-to-date (and plan for review)
Be accessible
The guideline writing committee needs to appraise the relevant evidence and then make a concrete recommendation regarding best practice
Recommendations go beyond the evidence—among other things, guideline writers need to consider context, values and cost
The guideline writing committee play an important role in formulating recommendations
This emphasises the importance of clear criteria for making recommendations and addressing conflicts of interest
Criteria for recommendations in systematic reviews and guidelines
Separates quality of evidence and strength of recommendation
| Quality of evidence | Strength of recommendation |
|---|---|
| High | Strong |
| Moderate | Weak |
| Low | |
| Very low |
The advice is very similar to applying the EBM hierarchy of evidence. Criteria are provided for shifting quality of evidence rating up or down, including:
Although observational studies … start with a “low quality” rating, grading upwards may be warranted if the magnitude of the treatment effects is very large (such as severe hip osteoarthritis and hip replacement), if there is evidence of a dose-response relation or if all plausible biases would decrease the magnitude of an apparent treatment effect
Guyatt, Oxman, Vist, et al. (2008, p. 926)
Determinants of strength of recommendation (Guyatt, Oxman, Kunz, et al., 2008):
Balance between desirable and undesirable effects
Quality of evidence
Values and preferences
Costs (resource allocation)
You can have a strong recommendation for treatment based on low quality evidence
You can frequently have a weak recommendation for treatment based on high quality evidence
Clear statement of intended use: improving the quality of care for patients with non-ST elevation acute coronary syndrome
Criteria for assessing evidence and providing recommendations
Clearly described policies regarding conflict of interest (but the link is not longer available!)
| Recommendation | Strength of Recommendation |
|---|---|
| Aspirin 300 mg orally initially (dissolved or chewed) followed by 100–150 mg/day is recommended for all patients with ACS in the absence of hypersensitivity. | Strong (IA) |
| Among patients with confirmed ACS at intermediate to very high- risk of recurrent ischaemic events, use of a P2Y12 inhibitor (ticagrelor 180 mg orally, then 90 mg twice a day or; prasugrel 60 mg orally, then 10 mg daily; or clopidogrel 300–600 mg orally, then 75mg per day) is recommended in addition to aspirin. (Ticagrelor or prasugrel preferred: see practice advice) | Strong (IA) |
| Recommendation | Strength of Recommendation |
|---|---|
| Aspirin (100–150 mg/day) should be continued indefinitely unless it is not tolerated or an indication for anticoagulation becomes apparent. | Strong (IA) |
| Clopidogrel should be prescribed if aspirin is contraindicated or not tolerated. | Strong (IA) |
| Dual-antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel or ticagrelor) should be prescribed for up to 12 months in patients with ACS, regardless of whether coronary revascularisation was performed. | Strong (IA) |
| Consider continuation of dual-antiplatelet therapy beyond 12 months if ischaemic risks outweigh the bleeding risk of P2Y12 inhibitor therapy; conversely consider discontinuation if bleeding risk outweighs ischaemic risks. | Weak (IIC) |
Treatment according to single-disease guidelines is likely to:
Give Susan a significant treatment burden
Under-estimate the harms of combined treatments (drug-disease interactions, drug-drug interactions)
Provide limited guidance on when treatments can be stopped: de-prescribing
Guidelines need to be implemented with care and common sense
Incorporate multimorbidity considerations into single disease clinical guidelines (Guthrie et al., 2017)
Guidelines for managing multimorbidity, such as NICE multimorbidity guidelines
Minimally disruptive medicine (MDM) is a patient-centered approach to care that focuses on achieving patient goals for life and health while imposing the smallest possible treatment burden on patients’ lives. It is particularly appropriate for patients who are at risk of being (or who already are) overwhelmed by the demands of life, illness, and health care.
Leppin et al. (2015, p. 51)
Conflicts of interests are common on clinical practice guidelines
There is limited data showing that conflicts of interest influence recommendations
But there are case studies of clear industry influence (Lenzer, 2013): high-dose steroids for acute spinal injury; exaggerated claims regarding alteplase for stroke
The tendency of a scientific study to support the interests of the study’s financial sponsor Wikipedia
Lundh et al. (2017) conducted a meta-analysis of reports of studies that assessed samples of papers for industry bias
Industry sponsored studies more often had favourable efficacy results (RR 1.27, 95% CI 1.17–1.37)
This effect is present despite industry sponsored studies possessing similar (or lower) risk of bias when compared to non-industry sponsored studies.
Transparency: clear reporting of conflicts of interest
Beware guidelines funded by sponsors
Linda is 31 years old, single, outspoken and very bright. She majored in philosophy. As a student, she was deeply concerned with issues of discrimination and social justice, and also participated in anti-nuclear demonstrations.
Which is more probable?
Linda is a bank teller
Linda is a bank teller and is active in the feminist movement
Qualitative descriptors of risk are interpreted differently: ‘high risk’, ‘low risk’,…
Numbers presented in different ways confuse people: which is worse, a death rate of 1286 out of 10,000 or a death rate of 24.14 out of 100?
Framing is important (and its effects depend on context): increasing survival or reducing death?
Both absolute and relative risks can be important, and each in isolation can be misleading; patients find NNT confusing
Need more work on the best way to numerically communicate uncertainty